US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Repurposed FDA-approved drug could uncover potential treatment for rare genetic disorders
In a new study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs ...
Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse
IQVIA reported annual sales for the twelve months ending September 2024 of $4.3 billion for the brand and generic market for this product. About Elite Pharmaceuticals, Inc.
Reuters4d
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
Pharmabiz2d
Azurity Pharma gets US FDA approval for Danziten tablets, the first and only nilotinib with no mealtime restrictions
Azurity Pharma gets US FDA approval for Danziten tablets, the first and only nilotinib with no mealtime restrictions: Woburn, Massachusetts Saturday, November 16, 2024, 17:00 Hrs ...
Autolus secures FDA approval for CAR-T cell therapy use in ALL
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy ...
GlobalData on MSN13d
FDA approves Journey Medical’s rosacea treatment Emrosi
Journey Medical's new rosacea treatment will rival industry giant Galderma's Oracea in the treatment of rosacea.
FDA moves to pull popular decongestant from shelves amid effectiveness concerns
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular ...
BioPharma Dive4d
PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review ...